Corazones Unidos: Heart health program for Mexican-origin adults
Pilot Test of Su Corazon Su Vida Among Mexican Origin Adults With MASLD
This program tests whether a community health worker-led education and support program can increase heart disease risk awareness and encourage healthy lifestyle changes for Mexican-origin adults with MASLD in Southern Arizona.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT07298213 on ClinicalTrials.gov |
What this trial studies
This is a community-based, community health worker (CHW)-led intervention focused on Mexican-origin adults diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Participants with a confirmed MASLD diagnosis (CAP ≥ 248 dB/m) will be paired with CHWs who provide education, risk communication, and support to promote lifestyle changes, and participants may enroll with an adult member of their social network. The primary aims are to determine the acceptability and feasibility of the intervention and its ability to increase cardiovascular risk awareness and uptake of healthier behaviors. Activities will be delivered in English or Spanish at the University of Arizona Collaboratory for Metabolic Disease Prevention & Treatment in Tucson, with outcome measures focused on engagement, self-reported behavior change, and implementation practicality.
Who should consider this trial
Good fit: Ideal candidates are Mexican-origin adults (≥18 years) with confirmed MASLD (CAP ≥ 248 dB/m), who can speak English or Spanish and have an adult social network member living within 25 miles willing to participate.
Not a fit: People who recently exceed alcohol consumption limits, do not have MASLD, live outside the Southern Arizona area, lack an eligible social support person, or cannot consent in English or Spanish may not benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could improve heart-health behaviors and reduce cardiovascular risk among Mexican-origin adults with MASLD.
How similar studies have performed: Community health worker interventions have improved cardiovascular risk factors in Hispanic and underserved populations, but CHW-led programs specifically targeting MASLD and linked CVD outcomes remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible intervention participants must (1) be Mexican-origin/Mexican decent, (2) be ≥ 18 years old, (3) have a confirmed MASLD diagnosis (CAP score of ≥ 248 dB/m); (4) have an adult member of their social network who might be interested in participating in the study and who lives within 25 miles of the participant's residence; (5) be able to provide informed consent; and (6) be able to speak, read, and write in English and/or Spanish. Eligible social support participants must (1) be ≥ 18 years old, (2) be first degree blood relative or spouse/significant other to the intervention participants, (3) be able to provide informed consent; and (4) be able to speak, read, and write in English and/or Spanish. Exclusion Criteria: * Exclusion for individuals interested in the intervention component of the study will be excluded if they report (1) ongoing or recent alcohol consumption (≥21 standard drinks on average per week in men and ≥14 standard drinks on average per week in women); (2) previous diagnosis of liver cancer; (3) taking any anti-inflammatory or hepatoxic medication regularly; (4) taking medication for any form of psychiatric disorders; (5) diagnosis of depression; (6) diagnosis of autoimmune disorders; or (7) women who are pregnant or breastfeeding due to hormonal changes. Exclusion for those interested to be part of the study as social network participants will not be considered for participation if they (1) live more than 25 miles of the intervention participant's residence.
Where this trial is running
Tucson, Arizona
- UA Collaboratory for Metabolic Disease Prevention & Treatment — Tucson, Arizona, United States (Recruiting)
Study contacts
- Study coordinator: Adriana Maldonado Assistant Professor, PhD
- Email: adrianamaldonado@arizona.edu
- Phone: 5206267279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.